Midazolam Sintetica 2 mg/2 ml
Midazolam Sintetica 2 mg/2 ml is a medicine authorised by Swissmedic under authorisation number 58875. The authorisation holder is Sintetica SA. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 22 April 2009 and the authorisation is valid without a time limit. ATC code N05CD08 places the medicine in the group Psycholeptics.
| Authorisation number | 58875 |
|---|---|
| Name | Midazolam Sintetica 2 mg/2 ml |
| Full name | Midazolam Sintetica 2 mg/2 ml, solution injectable |
| Authorisation holder | Sintetica SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N05CD08 |
| First authorisation | 22 April 2009 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Midazolam Sintetica 2 mg/2 ml, solution injectable | B | 22 April 2009 |
| 2 | Midazolam Sintetica 5 mg/1ml, solution injectable | B | 22 April 2009 |
| 3 | Midazolam Sintetica 5 mg/5 ml, solution injectable | B | 22 April 2009 |
| 4 | Midazolam Sintetica 15 mg/3 ml, solution injectable | B | 22 April 2009 |
| 5 | Midazolam Sintetica 50 mg/10 ml, solution injectable | B | 22 April 2009 |
| 6 | Midazolam Sintetica 50 mg/50 ml, solution injectable | B | 24 January 2020 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 10 | Ampulle(n) | N05CD08 | 01.03.1. | B |
| 2 | 10 | Ampulle(n) | N05CD08 | 01.03.1. | B |
| 3 | 10 | Ampulle(n) | N05CD08 | 01.03.1. | B |
| 4 | 10 | Ampulle(n) | N05CD08 | 01.03.1. | B |
| 5 | 10 | Ampulle(n) | N05CD08 | 01.03.1. | B |
| 6 | 1 | Durchstechflasche(n) | N05CD08 | 01.03.1. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Midazolam Sintetica 2 mg/2 ml authorised in Switzerland?
Yes. Midazolam Sintetica 2 mg/2 ml is authorised by Swissmedic under authorisation number 58875, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Midazolam Sintetica 2 mg/2 ml have?
Midazolam Sintetica 2 mg/2 ml is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Midazolam Sintetica 2 mg/2 ml?
The authorisation holder is Sintetica SA. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.